September 13, 2022
Case Validation: Once the new record or case is available in the safety data base, additional checks are performed for minimum criteria to ensure that the case is valid and/or to be sent for processing (e.g., patient, reporter, suspect product and adverse event). Additional checks may also include confirmation of whether the suspect product is…
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February 14, 2020
Prioritization/Triage: High-level assessment of key characteristics of source documents to determine cases of critical importance/urgency prior to data processing to ensure the case is processed in the appropriate timeline. Prioritization is typically based on factors such as death or life-threatening events, case seriousness, country-specific reporting timelines, association (relatedness), and/or expectedness. Once cases have been prioritized,…
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February 14, 2020
Duplicate Check: An additional duplicate check is commonly performed to confirm the intake decision of whether the case is a follow-up of a previous version, a true duplicate, or a new initial case. In 2020:70% of respondents were applying at least some level of automation.30% of respondents reported no automation of this ICSR process step.In…
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February 14, 2020
Data Acquisition: Acquisition of data to the case processing workflow. This can be through integration with the case intake system or through e-mail etc. May be automated from local intake system. In 2020:60% of respondents were applying at least some level of automation.40% of respondents reported no automation of this ICSR process step.In 2021:72% of…
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January 16, 2020
Narrative Writing: A full and comprehensive case narrative should be written by constructing a stand alone prose summary of the case. When possible, identification of new information / changes for follow-up cases should be highlighted. In 2020:85% of respondents were applying at least some level of automation.15% of respondents reported no automation of this ICSR…
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January 16, 2020
Monitoring: Periodic, post-processing monitoring is generally done to ensure the requested follow-up activities have been done for the case prior to close-out. Reminders are sent if needed. Once due diligence is completed, the follow-up tracking can be closed. In 2020:35% of respondents were applying at least some level of automation.65% of respondents reported no automation…
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January 16, 2020
Follow-Up Questions: Identify any follow-up activities or case clarifications (e.g., queries). This can be basic information and clarification, or it can be a request for more in depth questionnaire driven information. Record the required communication and send the query. In 2020:70% of respondents were applying at least some level of automation.30% of respondents reported no…
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January 16, 2020
In-Line QC: Proper quality checks of data entry should be in place to ensure the case is medically sound, accurate and complete, and that appropriate follow-up actions have been taken prior to completion of the case processing / release. In 2020:55% of respondents were applying at least some level of automation.45% of respondents reported no…
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January 16, 2020
Coding: Assignment of structured medical dictionary terms, including MedDRA and WHODrug terms, to clinical concepts are usually assigned. In 2020:75% of respondents were applying at least some level of automation.25% of respondents reported no automation of this ICSR process step.In 2021:89% of respondents were applying at least some automation.11% of respondents reported no automation of…
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January 16, 2020
Medical Assessment: Medical assessment of the completeness of the case should be performed, including a causality assessment where required and ensuring labeling information is added and accurate. In 2020:60% of respondents were applying at least some level of automation.40% of respondents reported no automation of this ICSR process step.In 2021:67% of respondents were applying at…
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